Senior Quality Engineer - Medical Devices: Design Controls

Intuitive; California (MO); On-site; USD 90,000 - 130,000; Full time

Job summary

Intuitive Surgical seeks a Quality Engineer to lead design controls, risk management, verification and validation for next-generation surgical systems. You will collaborate with cross-functional teams to ensure products meet internal quality standards and external regulatory requirements.

The role emphasizes regulatory support, design transfer to manufacturing, and continuous improvement of quality processes across the product lifecycle.

Qualifications

• Bachelor's degree in an engineering or related field; Advanced degree preferred.
• Expertise in medical device standards (ISO 14971, IEC 60601, IEC 62304, ISO 80002-1) and FDA Design Controls.
• Experience in risk-based V&V, process validation, and reliability testing.

Responsibilities

• Design Controls, risk management, and design verification/validation for new products.
• Support design transfer to manufacturing and supplier qualification.
• Assist Regulatory Affairs with submissions and audits.
• Drive continuous improvement of design control and risk management processes.

Education

Bachelor's degree in Electrical Engineering, Mechanical Engineering, Computer Science, software engineering, or biomedical engineering

Advanced Degree

Tools

Regulatory standards (ISO 14971, IEC 60601, IEC 62304, ISO 80002-1)

Job description

Intuitive Surgical seeks a Quality Engineer to lead design controls, risk management, verification and validation for next-generation surgical systems. You will collaborate with cross-functional teams to ensure products meet internal quality standards and external regulatory requirements.

The role emphasizes regulatory support, design transfer to manufacturing, and continuous improvement of quality processes across the product lifecycle.